Trial Outcomes & Findings for ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer (NCT NCT00394082)
NCT ID: NCT00394082
Last Updated: 2019-11-25
Results Overview
Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
up to 25 months
Results posted on
2019-11-25
Participant Flow
Participant milestones
| Measure |
ABI-007 Plus Bevacizumab
ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
At Least One Response Assessment
|
43
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
ABI-007 Plus Bevacizumab
ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
|
|---|---|
|
Overall Study
Unacceptable toxicity
|
15
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
ABI-007 Plus Bevacizumab
n=50 Participants
ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
|
|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic and Non-Latino
|
40 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Hispanic or Latino
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
|
Weight
|
74.52 kilograms
STANDARD_DEVIATION 15.430 • n=5 Participants
|
|
Menopausal status
Pre-menopausal
|
7 participants
n=5 Participants
|
|
Menopausal status
Post-menopausal
|
43 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) status
0 (Fully Active)
|
23 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) status
1 (Restrictive but Ambulatory)
|
25 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) status
2 (Ambulatory but Unable to Work)
|
2 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) status
3 (Limited Self-Care)
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) status
4 (Completely Disabled)
|
0 participants
n=5 Participants
|
|
Time from First Documented Metastasis/Relapse to Study Entry
|
1.01 years
STANDARD_DEVIATION 3.123 • n=5 Participants
|
|
Dominant Current Site of Metastasis/Relapse
Visceral
|
49 participants
n=5 Participants
|
|
Dominant Current Site of Metastasis/Relapse
Non Visceral
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 25 monthsPopulation: Safety population
Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug.
Outcome measures
| Measure |
ABI-007 Plus Bevacizumab
n=50 Participants
ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
|
|---|---|
|
Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
|
50 participants
|
PRIMARY outcome
Timeframe: up to 39 monthsPopulation: Treated population.
Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first. Patients who do not have disease progression or have not died at the end of follow-up were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Response Evaluation Criteria in Solid Tumors (RECIST) defines progressive disease (PD) as a \>= 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.
Outcome measures
| Measure |
ABI-007 Plus Bevacizumab
n=50 Participants
ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
|
|---|---|
|
Kaplan-Meier Estimates for Progression-free Survival
|
8.0 months
Interval 5.3 to 10.3
|
SECONDARY outcome
Timeframe: up to 39 monthsPopulation: Treated population.
Objective response is complete response (CR) + partial response (PR). RECIST defines overall response of CR as the disappearance of all target and non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. Overall response of PR is defined as \>= 30% decrease from baseline in the sum of the longest diameters of target lesions and no progression of non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing and no appearance of new lesions. The objective response is determined by combining the response of target and non-target lesions and the appearance of new lesion(s) or not together.
Outcome measures
| Measure |
ABI-007 Plus Bevacizumab
n=50 Participants
ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
|
|---|---|
|
Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Overall response (CR + PR)
|
30 percentage of participants
Interval 17.3 to 42.7
|
|
Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Complete response (CR)
|
0 percentage of participants
not defined in analysis plan
|
|
Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Partial response (PR)
|
30 percentage of participants
not defined in analysis plan
|
SECONDARY outcome
Timeframe: up to 39 monthsPopulation: Treated population
Disease control is stable disease (SD) for \>=16 weeks + complete response (CR) + partial response (PR). RECIST defines SD as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease and no new lesions. Definitions for CR and PR can be found in outcome #3.
Outcome measures
| Measure |
ABI-007 Plus Bevacizumab
n=50 Participants
ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
|
|---|---|
|
Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
CR + PR + SD>=16 weeks
|
50 percentage of participants
Interval 36.1 to 63.9
|
|
Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Complete response (CR)
|
0 percentage of participants
not defined in analysis plan
|
|
Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Partial response (PR)
|
30 percentage of participants
not defined in analysis plan
|
|
Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Stable disease >=16 weeks (SD>=16 weeks)
|
20 percentage of participants
not defined in analysis plan
|
SECONDARY outcome
Timeframe: up to 39 monthsPopulation: Treated population of participants who had a response.
Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progressive disease is defined in outcome #2. Complete response (CR) and partial response (PR) are defined in outcome #3.
Outcome measures
| Measure |
ABI-007 Plus Bevacizumab
n=15 Participants
ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
|
|---|---|
|
Kaplan-Meier Estimate for Duration of Response
|
10.3 months
Interval 9.0 to 20.8
|
SECONDARY outcome
Timeframe: up to 39 monthsPopulation: Treated population
Participant survival is the time from the first dose of study drug to patient death from any cause. Patients that did not die were censored at the last known time the patient was alive.
Outcome measures
| Measure |
ABI-007 Plus Bevacizumab
n=50 Participants
ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
|
|---|---|
|
Kaplan-Meier Estimates for Participant Survival
|
17.1 months
Interval 13.7 to 23.8
|
Adverse Events
ABI-007 Plus Bevacizumab
Serious events: 13 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABI-007 Plus Bevacizumab
n=50 participants at risk
ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.0%
3/50 • up to 25 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50 • up to 25 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • up to 25 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
2.0%
1/50 • up to 25 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
2.0%
1/50 • up to 25 months
|
|
Injury, poisoning and procedural complications
Pneumonitis chemical
|
2.0%
1/50 • up to 25 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
2.0%
1/50 • up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50 • up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/50 • up to 25 months
|
|
Gastrointestinal disorders
Pancreatitis
|
2.0%
1/50 • up to 25 months
|
|
Hepatobiliary disorders
Cholangitis
|
2.0%
1/50 • up to 25 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.0%
1/50 • up to 25 months
|
|
Immune system disorders
Anaphylactic reaction
|
2.0%
1/50 • up to 25 months
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • up to 25 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
2.0%
1/50 • up to 25 months
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • up to 25 months
|
|
Psychiatric disorders
Bipolar disorder
|
2.0%
1/50 • up to 25 months
|
Other adverse events
| Measure |
ABI-007 Plus Bevacizumab
n=50 participants at risk
ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
|
|---|---|
|
Nervous system disorders
Headache
|
36.0%
18/50 • up to 25 months
|
|
Nervous system disorders
Neuropathy
|
30.0%
15/50 • up to 25 months
|
|
Nervous system disorders
Neuropathy peripheral
|
26.0%
13/50 • up to 25 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.0%
13/50 • up to 25 months
|
|
Nervous system disorders
Dizziness
|
16.0%
8/50 • up to 25 months
|
|
Nervous system disorders
Dysgeusia
|
16.0%
8/50 • up to 25 months
|
|
Nervous system disorders
Hypoaesthesia
|
6.0%
3/50 • up to 25 months
|
|
Nervous system disorders
Paraesthesia
|
6.0%
3/50 • up to 25 months
|
|
Gastrointestinal disorders
Nausea
|
68.0%
34/50 • up to 25 months
|
|
Gastrointestinal disorders
Diarrhoea
|
38.0%
19/50 • up to 25 months
|
|
Gastrointestinal disorders
Constipation
|
32.0%
16/50 • up to 25 months
|
|
Gastrointestinal disorders
Vomiting
|
26.0%
13/50 • up to 25 months
|
|
Gastrointestinal disorders
Abdominal distension
|
14.0%
7/50 • up to 25 months
|
|
Gastrointestinal disorders
Abdominal pain
|
14.0%
7/50 • up to 25 months
|
|
Gastrointestinal disorders
Stomatitis
|
12.0%
6/50 • up to 25 months
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
4/50 • up to 25 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.0%
4/50 • up to 25 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.0%
3/50 • up to 25 months
|
|
Gastrointestinal disorders
Flatulence
|
6.0%
3/50 • up to 25 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
62.0%
31/50 • up to 25 months
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
24.0%
12/50 • up to 25 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.0%
11/50 • up to 25 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
10.0%
5/50 • up to 25 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
4/50 • up to 25 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.0%
4/50 • up to 25 months
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
8.0%
4/50 • up to 25 months
|
|
General disorders
Fatigue
|
70.0%
35/50 • up to 25 months
|
|
General disorders
Oedema peripheral
|
24.0%
12/50 • up to 25 months
|
|
General disorders
Asthenia
|
18.0%
9/50 • up to 25 months
|
|
General disorders
Mucosal inflammation
|
16.0%
8/50 • up to 25 months
|
|
General disorders
Pyrexia
|
14.0%
7/50 • up to 25 months
|
|
General disorders
Pain
|
12.0%
6/50 • up to 25 months
|
|
General disorders
Chills
|
10.0%
5/50 • up to 25 months
|
|
General disorders
Infusion site pain
|
6.0%
3/50 • up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
52.0%
26/50 • up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
34.0%
17/50 • up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.0%
13/50 • up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
18.0%
9/50 • up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.0%
6/50 • up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.0%
6/50 • up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.0%
4/50 • up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.0%
3/50 • up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
6.0%
3/50 • up to 25 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
20/50 • up to 25 months
|
|
Blood and lymphatic system disorders
Anaemia
|
28.0%
14/50 • up to 25 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.0%
5/50 • up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
10/50 • up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.0%
7/50 • up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
5/50 • up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
5/50 • up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
4/50 • up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.0%
3/50 • up to 25 months
|
|
Infections and infestations
Urinary tract infection
|
22.0%
11/50 • up to 25 months
|
|
Infections and infestations
Upper respiratory tract infection
|
14.0%
7/50 • up to 25 months
|
|
Infections and infestations
Cellulitis
|
6.0%
3/50 • up to 25 months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
6.0%
3/50 • up to 25 months
|
|
Vascular disorders
Hypertension
|
28.0%
14/50 • up to 25 months
|
|
Vascular disorders
Hot flush
|
8.0%
4/50 • up to 25 months
|
|
Vascular disorders
Hypotension
|
6.0%
3/50 • up to 25 months
|
|
Vascular disorders
Lymphoedema
|
6.0%
3/50 • up to 25 months
|
|
Psychiatric disorders
Insomnia
|
24.0%
12/50 • up to 25 months
|
|
Psychiatric disorders
Anxiety
|
10.0%
5/50 • up to 25 months
|
|
Metabolism and nutrition disorders
Anorexia
|
18.0%
9/50 • up to 25 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
5/50 • up to 25 months
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
4/50 • up to 25 months
|
|
Eye disorders
Vision blurred
|
10.0%
5/50 • up to 25 months
|
|
Eye disorders
Conjunctivitis
|
8.0%
4/50 • up to 25 months
|
|
Eye disorders
Lacrimation increased
|
6.0%
3/50 • up to 25 months
|
|
Renal and urinary disorders
Dysuria
|
12.0%
6/50 • up to 25 months
|
|
Renal and urinary disorders
Proteinuria
|
8.0%
4/50 • up to 25 months
|
|
Investigations
Weight decreased
|
8.0%
4/50 • up to 25 months
|
|
Investigations
Neutrophil count decreased
|
6.0%
3/50 • up to 25 months
|
|
Investigations
White blood cell count decreased
|
6.0%
3/50 • up to 25 months
|
|
Cardiac disorders
Palpitations
|
6.0%
3/50 • up to 25 months
|
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it has been more than 2 years since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decided publication would hinder patent applications, Investigator must delay submission for up to 1 year. Investigator must delete confidential information before submission.
- Publication restrictions are in place
Restriction type: OTHER